Using Limosilactobacillus reuteri probiotics to help treat periodontitis

Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis: A Randomized Controlled Trial

This study is testing if a probiotic lozenge can help people with periodontitis improve their gum health when used alongside regular treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universidade do Porto (Academic / other)
• Locations: 1 site (Oporto)
• Trial ID: NCT05734274 on ClinicalTrials.gov

What this trial studies

This study evaluates the clinical efficacy of a probiotic lozenge containing Limosilactobacillus reuteri as an adjunct to non-surgical treatment for patients with stage II, grade A, B, and C generalized periodontitis. The primary focus is on assessing the impact of the probiotic on disease progression, measured by Bleeding on Probing (BoP). Secondary outcomes include changes in Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), and Clinical Attachment Level (CAL) compared to a negative control. Participants will be monitored for improvements in periodontal health over the course of the study.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with a definitive diagnosis of stage II, grade A, B, or C generalized periodontitis and at least three natural teeth in each quadrant.

Not a fit: Patients with systemic pathologies, recent periodontal treatment, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the effectiveness of periodontal treatments and improve oral health outcomes for patients with periodontitis.

How similar studies have performed: While the use of probiotics in periodontal treatment is a growing area of interest, this specific approach with Limosilactobacillus reuteri is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Patients over 18 years old, who intend to voluntarily participate in the study and:

  * Have a definitive diagnosis of stage II, grade A, B or C, generalized periodontitis (2018, World Workshop);
  * Have at least 3 natural teeth maintained per quadrant.

Exclusion Criteria:

* • Patients unable to understand the instructions necessary to participate in the study or unable to give informed consent;

  * Patients who have received any type of periodontal treatment 2 months prior to the start of study participation;
  * Pregnant or breastfeeding patients;
  * Patients with associated systemic pathology, such as diabetes, HIV, asthma, hyperthyroidism, immune system pathologies, lichen erosive or other pathologies treated with corticosteroids or immunosuppressants;
  * Patients undergoing therapy with drugs that may interfere with the response of the gingival tissues: anti-inflammatory drugs, anticonvulsants (phenytoin and sodium valproate), immunosuppressants (cyclosporin-A and tacrolimus) and antihypertensives (nifedipine and verapamil hydrochloride);
  * Patients undergoing anticoagulant therapy;
  * Patients allergic to both lidocaine, articaine and mepivacaine;
  * Patients who require antibiotic prophylaxis for bacterial endocarditis;
  * Patients who have had antibiotic therapy within 2 months of study participation;
  * Patients using chlorhexidine, or other mouthwashes or elixirs;
  * Patients undergoing orthodontic treatment.

Where this trial is running

Oporto

• Faculty of Dental Medicine - University of Porto — Oporto, Portugal (Recruiting)

Study contacts

• Principal investigator: André Marques, MDent — Estudante da Especialização de Periodontologia e Implantologia
• Study coordinator: André Marques, MDent

Conditions Chronic Periodontitis, Generalized; probiotics; Limosilactobacillus reuteri